Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT04455932
Eligibility Criteria:
Inclusion criteria
* Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as vascular or congenital fibrosis) AND reduced visualisation of their liver on ultrasound (vB and vC).
* The criteria of cirrhosis can be obtained with any of the following methods:
1. Histologically by liver biopsy
2. Past signs of decompensated liver disease such as ascites, encephalopathy, varices or bacterial peritonitis
3. Clinically suspicion of cirrhosis PLUS one of the following:
1. Radiological evidence of morphologic changes of the liver and evidence of portal hypertension on US, CT or MRI examinations, including the identification of hepatic surface nodularity, splenomegaly, portal collaterals, varices and ascites
2. Fibroscan (transient elastography) median liver stiffness \>12.5 kPa, the Fibroscan must be performed by an experienced technician and interpreted by the hepatologist
3. Platelet count \<100 (x10\^9/L) with no alternative cause
* Absence of previous history or current suspicion of HCC - Absence of HCC is defined by liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance
* Patient is able to comply with scheduled visits, evaluation plans and other study procedures in the opinion of the investigator
* Patient is willing to provide written informed consent
Exclusion criteria
* Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)
* Contraindications to gadolinium
* Age above 85 years old or younger than 20 years old
* Pregnancy or breast feeding
* Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment for the trial or could interfere with the completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT04455932
Study Brief:
Protocol Section:
NCT04455932